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Everything you need to know about ISO 9001 Documentation Toolkit


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If you decide to go with self-implementation, you can find lots of resources and tools available to you, including free documents and downloads on the Internet. Our Virtual Consultant is here to offer independent advice you may not find anywhere else.

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More detail and advice in our ISO 9001 Blog

How to manage the medical device sterilization process according to ISO 13485:2016

Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical devices are not properly sterilized. As a result, many patients die, while many more are diagnosed with various infections after surgery, and other complications also arise due to a lack ...Read more

How to meet ISO 13485:2016 requirements for medical device files

The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to create consistent operations for medical device manufacturers, and also to make their Quality Management Systems compliant with the rules of various regulatory bodies. Manufacturers and suppliers of medical devices must ...Read more

Managing medical device infrastructure requirements according to ISO 13485:2016

The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure, no firm can carry out its activities. Infrastructure includes buildings, workspaces, utilities, process equipment, instruments, information technology systems, and transportation mechanisms. Similarly, all companies involved in medical device manufacturing or distribution shall maintain a ...Read more

How to sell your ISO 9001 consulting services

ISO 9001:2015 is the premier standard for Quality Management System (QMS) and business management, and, for many organizations, it is the “entry level” to enable them to compete for business through formal tender processes with large organizations. In addition to the benefits for the organization, we also considered employee benefits ...Read more

Where does quality management / ISO 9001 fit into your organization?

ISO 9001 is the premier business standard used to facilitate the satisfaction of customers through effective operation of a Quality Management System. More than 1.5 million certificates were awarded in 2015 (source:, which represented a 3% increase over the previous year; therefore, ISO 9001 continues to grow in importance ...Read more

How can a startup benefit from ISO 9001?

ISO 9001:2015 implementation and certification may not always be at the top of a startup’s wish list, given the financial and operational pressures many new businesses find themselves under in the early stages of development. With decisions to be made in terms of what projects cost and the benefits they ...Read more

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